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In this issue of our esteemed Journal, section editor of the psychopharmacology column, Dr. Dean Elbe, teamed up with an endocrinologist, a research assistant and child psychiatrists to present the current evidence focusing on the efficacy but mostly the metabolic safety profiles of atypical antipsychotic use in children and adolescents. The column was vetted as well through Dr. Elbe’s co-editors of the column.
With the controversy about the vertiginous rise in prescription rates of atypical antipsychotics over the last few years, the questions about the risk/benefit profile of this category of drugs, prescribed mostly in off-label indications in pediatric psychopharmacology, will be coming in fast and furious now. Is clinical practise out of touch with the available evidence base? Why have guidelines regulating efficacy and safety not been instituted earlier? Are those psychiatrists who are formulating prescribing guidelines in a conflict of interest position (COI) if they have links to pharma? In the off-label environment what constitutes the appropriate standard of care? What constitutes a comprehensive informed consent? And of course, have psychiatrists, from those wined and dined at drug-company sponsored events, to those collecting speaking engagement fees to those sitting on consultation boards formulating guidelines, been unduly influenced by drug companies and their powerful advertising lobbies? We have all been influenced in one way or another, present company included.
Without demonizing Big Pharma, the bottom line is that they are in the business of making money while we are in the business of providing the best clinical care possible. Atypical antipsychotics are one of the largest markets for pharmaceutical manufacturers, representing over 14.6 billion dollars in sales per year (USA alone, 2008, imshealth.com). Therefore companies have strong incentives to “expand their market” but while growth is limited in the on-label indication environment (i.e. schizophrenia and to some extent bipolar disorder), off-label indications especially for the elderly and children and youth are “potential growth areas”. Drug companies cannot directly advertise for off-label use but can do so indirectly through “incentives” to willing psychiatrists. In the USA, several states have attempted to make this issue more transparent by requiring pharmaceutical companies to disclose their payments to physicians. In a New York Times article (Psychiatrists, Children and Drug Industry’s Role, 10/05/2007) authors Gardiner Harris, Benedict Carey and Janet Rogers report that in the state of Minnesota, where records have been tracked since 1992, from 2000 to 2005, drug company payments to Minnesota psychiatrists rose more than six-fold to 1.6 million and prescriptions for antipsychotics for children in the Medicaid program rose more than nine-fold. For the same period of time, psychiatrists receiving less than $5000 a year from drug companies wrote on average 67 prescriptions for atypicals per year whereas those psychiatrists receiving over $5000 per year, on average, wrote 223 prescriptions for atypicals per year. These observations are correlational rather than proof of cause and effect but other studies have indicated a consistent pattern of increased use as well beyond diagnostic indications (see Panagiotopoulos et al., this issue).
Are psychiatrists more vulnerable to pharma’s influence than colleagues in other branches of medicine? Again the same data from Minnesota’s Medicaid indicates that psychiatrists are more likely to receive financial incentives than other specialists. We can speculate on the reasons for this state of affairs (poor salaries? primitive state of diagnostics? complexity of mind-brain interactions? psychiatric identity problems?) but I have not yet seen a really cogent analysis of the various medical, social, cultural and economic factors influencing physician drug prescription decision-making.
It is hypocritical to bite the hand that feeds since the Journal accepts advertising dollars and the Academy accepts sponsorship monies for our annual conference. So can we do better? There are certain actions that can be taken to ensure arms length relationships in the interest of protecting the children and families who consult us. We can start by educating ourselves better about how the marketing strategies of Big Pharma work as they cannot sell their products without us. While there can be board-room secrets there is enough information out there to deduce motivations, and data from research firms is available for marketing trend analysis (e.g. www.researchandmarkets.com). Practitioners should have knowledge of relatively unbiased groups (i.e. non pharma funded) conducting quality evidence based reviews such as AHRQ (Agency for Health Care Research and Quality, a branch of the US Human Health Services) and Cochrane Reviews. Other non profit organizations such as Prescription Policy Choices, (www.policychoices.org) based in Maine, are studying the escalating use of antipsychotics in children from a public policy perspective, and tracking what states are doing to safeguard children against the clinically inappropriate use of these drugs. Clinicians should familiarize themselves with the FDA approval process relating to the use of these drugs in children. For example the recent decision by an FDA panel of experts to approve quetiapine, olanzapine and ziprasidone for schizophrenia and bipolar disorder in the 10 to 17 age group was not a unanimous decision but represented committee member consensus with many against and many abstentions (Kuehn, 2009).
Finally, while the culture in our subspecialty has been to commonly prescribe medications in an off-label fashion due to a lack of available evidence, this needs to change as more evidence of efficacy becomes available, and the risk of the serious adverse events these medications can cause becomes more well-defined. There are often guidelines about what to prescribe but not guidelines about what not to prescribe as new evidence emerges. Utilization data capturing trends over years should be reviewed at annual meetings and conferences as standing items. Articles such as the one by Panagiotopoulos et al. and prescribing guidelines that gather together evidence regarding drug efficacy, adverse events and recommended monitoring are valuable and essential in our field.
I would like to sincerely thank Jennifer Reck, MA from Prescription Policy Choices for many of the ideas discussed in this editorial.